FDA 510(k) Clearance
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Regulatory
Orthofix Announces FDA Clearance and First Patient Implant of the 3D-Printed FORZA Titanium TLIF Spacer System with Nanovate Technology
Designed for TLIF procedures, the 3D-printed FORZA Ti Spacer System further expands the comprehensive line of PEEK, PTC, and now…
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Recon
Zimmer Biomet Receives FDA Clearance for ROSA® Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty
WARSAW, Ind., April 20, 2021 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today…
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Regulatory
Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization
BOSTON, April 9, 2021 /PRNewswire/ — Activ Surgical™, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of…
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Regulatory
Orthofix Announces FDA Clearance and Initial Patient Implant of the Company’s First 3D-Printed Titanium Cervical Spacer System with Nanovate Technology
April 5, 2021 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and extremities focus,…
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Regulatory
Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate
CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF),…
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Regulatory
Life Spine Announces FDA 510(k) Clearance for the PROLIFT® Wedge Expandable Spacer System
March 18, 2021 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a leading medical device company that designs, develops, manufactures and markets products for…
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Recon
Catalyst OrthoScience receives FDA 510(K) clearance of its reverse shoulder system
Reverse system allows Catalyst to address vast majority of shoulder arthroplasty market; Limited user release expected in Q2 2021 NAPLES,…
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Extremities
Leith Medical Announces FDA Clearance
March 10, 2021 [Austin, TX February 23, 2021] Leith Medical announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the…
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Extremities
Acuitive Technologies Granted FDA 510(k) Clearance for CITREFIX™ Knotless Suture Anchor
ALLENDALE, N.J., Feb. 11, 2021 /PRNewswire/ — Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the…
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Spine
Precision Spine® Receives FDA 510(K) Clearance for the Dakota ACDF™ Standalone System
February 4, 2021 PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, announced today that it…
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Regulatory
ChoiceSpine™ Announces Line Extension of Tiger Shark™ Cervical Spacer System
January 25, 2021 KNOXVILLE, Tenn.–(BUSINESS WIRE)–ChoiceSpine LLC, a privately held spinal device manufacturer based in Knoxville, TN, announced today that…
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Recon
DePuy Synthes Receives 510(k) FDA Clearance for VELYS™ Robotic-Assisted Solution Designed for Use with the ATTUNE® Total Knee System
PALM BEACH GARDENS, Fla., Jan. 19, 2021 /PRNewswire/ — Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes** has…
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Regulatory
SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene® Surface Technology
CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on…
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Regulatory
icotec ag Receives FDA Clearance for the VADER® Pedicle – System with Bone Cement Augmentation
ALTSTAETTEN, Switzerland, Nov. 10, 2020 /PRNewswire/ — icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System
IRVING, TX – November 9, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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